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Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer Harboring Specific Molecular Alterations

Last updated on September 8, 2019

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Study Location
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Cancer Harboring Molecular Alterations
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Ineligibility for participation in any ongoing clinical study of the investigational
product

- Age ≥18 years

- Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK
rearrangement

- Failure of all locally approved ALK/ROS1 inhibitors or at least one approved
chemotherapy regimen or at least one approved immunotherapy agent

- ECOG Performance Status 0, 1, or 2

- Adequate bone marrow, liver, renal, pancreatic functions

- negative pregnancy test at screening

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or
participation in other studies with investigational drugs within the timeframe
indicated in the protocol

- History of interstitial fibrosis or interstitial lung disease

- Concomitant use of prohibited medication

- Clinically significant cardiovascular disease: cerebral vascular accident/stroke,
myocardial infarction, unstable angina, congestive heart failure, second degree or
third degree atrioventricular block (unless paced) or any AV block with PR >220 msec

- Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with
QTc >470 msec, or congenital long QT syndrome

- History of or predisposing characteristics for acute pancreatitis

- Symptomatic brain metastases

NCT03178071
Pfizer
Available
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer Harboring Specific Molecular Alterations

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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